The Evaluation of a Noninvasive Respiratory Monitor in Intubated Infants

October 4, 2021 updated by: Viviane Nasr, Boston Children's Hospital

In this research study, the investigators want to learn more about whether the Respiratory Volume Monitor (ExSpiron) can accurately measure breathing in infants less than 12 months of age. The Respiratory Volume Monitor uses up to 5 stickers that are placed on the chest to measure the amount of air going in and out of the lungs with each breath (Tidal Volume), the number of times per minute a breath is taken (Respiratory Rate), and the amount of air going in and out of the lungs per minute (Minute Ventilation).

It is important for medical staff to be able to collect information about breathing non-invasively because it may help determine if certain children are experiencing breathing problems sooner than the way it is currently detected.

The goal of this study is to determine if the Respiratory Volume Monitor works accurately in infants less than 12 months of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Intubated infants less than 12 months of age who are admitted to an Intensive Care Unit

Description

Inclusion Criteria:

  • less than 12 months of age
  • currently intubated in the ICU

Exclusion Criteria:

  • ExSpiron monitor will interfere with a healing surgical procedure site or standard of care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants less than 12 months
intubated infants in ICU
Device: Respiratory Volume Monitor
Other Names:
  • ExSpiron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Respiratory rate accurately measured by the ExSpiron monitor during controlled ventilation
Time Frame: During 1 hour period in ICU
During 1 hour period in ICU
Tidal Volume accurately measured by the ExSpiron monitor during controlled ventilation
Time Frame: During 1 hour period in ICU
During 1 hour period in ICU
Minute ventilation accurately measured by the ExSpiron monitor during controlled ventilation
Time Frame: During 1 hour period in ICU
During 1 hour period in ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Viviane Nasr, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

September 9, 2016

First Submitted That Met QC Criteria

September 13, 2016

First Posted (Estimate)

September 14, 2016

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-P00023229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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